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CompletedNCT02833532Updated Aug 8, 2017

A Multi-center, Randomized, Subject Blind, Active Controlled Design Clinical Study to Evaluate the Efficacy and Safety of Volus as Compared to PowerFill® for Temporary Penile Enhancement

A Phase 3 interventional study of Volus/Powerfill in Penile Enhancement, sponsored by Hugel. Completed at 1 site in South Korea. Open to male participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-08.

Sponsored by Hugel · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
Male
01

Study summary

The purpose of this study is to evaluate non-inferial study of the after using Volus application, compared to the powerfill.

02

Conditions studied

  • Penile Enhancement
03

In context

Lead sponsor

Hugel is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male subjects aged above 20 and below 65. (20≤male≥65)
  2. be rating himself, when screening, as "Small or Very Small" on Self-Questioned Questionnaire ( SQQ) including the question: " How do you rate your penile size? // Very small, Small, Normal, Big, Very Big?"
  3. During the study period, subjects will not received any treatments associated with penile enhancement.
  4. Subjects will sign an informed consent form

Exclusion criteria

Exclusion Criteria:

  1. Prior treatment for penile enhancement (e.g. fat, dermal graft).
  2. Subjects who have penile malformation (e.g. Peyronie's disease), which can make impossible to perform the intervention
  3. Allergic to hyalluronic acid.
  4. Inflammatory or/and infectious disease on penis that can affect on this study
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
68 participants (estimated)

Study arms

  • Experimental
    Volus

    Maxium: 22ml

    Device: Volus/Powerfill

  • Active comparator
    Powerfill

    Maxium: 22ml

    Device: Volus/Powerfill

Interventions

  • DeviceVolus/Powerfill

    Maximum: 22ml

06

What researchers measure

Primary outcomes

  1. the Penile Circumference difference at 24 weeks from Baseline value after using Volus application, compared to the Control.

    Penile Circumference: The average of Distal-, Mid-, and Proximal-penis measurements when relaxed by tape measurement. Baseline value: Measured baseline length before the intervention.

    Time frame: baseline, 24 weeks

Secondary outcomes

  1. The Difference in Penile Circumference (each to be measured) at 4, 12 weeks (post last treatment) from Baseline value after using Volus application, compared to the Control.

    Time frame: baseline, 4 weeks, 12 weeks, 24 weeks

  2. The Difference in 5-point scale of penile appearance (each to be measured) at 4, 12, 24 weeks (post last treatment) from Baseline value after using Volus application, compared to the Control.

    Time frame: baseline, 4 weeks, 12 weeks, 24 weeks

  3. The Difference in 5-point scale of sexual satisfaction (each to be measured) at 12, 24 weeks (post last treatment)from Baseline value after using Volus application, compared to the Control.

    Time frame: baseline, 12 weeks, 24 weeks

  4. The Difference in penile length† (each to be measured) at 4, 12, 24 weeks (post last treatment) from ‡B after using Volus application, compared to the Control.

    † penile length: A length of penile distribution measured from the ventral side of pubo-penile skin junction to the apex of prepuce when relaxed using a tape( or stick)- measure.

    Time frame: baseline, 4 weeks, 12 weeks, 24 weeks

07

Study locations

1 site
  • HUGEL
    Seoul, South Korea
08

References and documents

Publications

  • Yang DY, Ko K, Lee SH, Lee WK. A Comparison of the Efficacy and Safety Between Hyaluronic Acid and Polylactic Acid Filler Injection in Penile Augmentation: A Multicenter, Patient/Evaluator-Blinded, Randomized Trial. J Sex Med. 2019 Apr;16(4):577-585. doi: 10.1016/j.jsxm.2019.01.310. Epub 2019 Mar 2. PubMed 30833149 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2015, a primary completion of Jan 2017 and a completion of Jun 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 12, 2016
First posted
Jul 14, 2016
Start
Jun 2015
Primary completionActual
Jan 2017
CompletionActual
Jun 2017
Last update
Aug 8, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02833532
Lead sponsor
Hugel
Collaborators
Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials
Responsible party
Sponsor
First posted
Jul 14, 2016
Start date
Jun 2015
Primary completion
Jan 2017
Completion
Jun 2017
Last update
Aug 8, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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